In order to pass a suture through a tubular organ or other structure in a body (a human body or an animal), it is necessary to traverse the bodily structure, tissue or organ completely and encircle the area where the physician or medical practitioner wishes to place the suture. This traverse and encircle method works well in situations where easy access is available to the structure, tissue or organ and the item to be sutured is easily viewed by the physician. In limited access situations (for example, in laparoscopic surgery, cardiac surgery and vascular surgery), the traverse and encirclement by sutures is often times difficult, dangerous and at other times impossible.
As a further example, an attempt to suture a blood vessel through a small puncture wound is almost impossible. The direct suture of the arterial puncture is not possible.
The increasing utilization of minimally invasive surgical techniques has created a need for improved methods, suture systems and suture placement devices under adverse conditions of limited access and limited visibility of the suture site.
U.S. Pat. No. 5,860,990 to Nobles et al. discloses a suturing device which includes sutures attached to needle points. The needle points are press fit onto the ends of delivery arms. The delivery arms are made of memory-shape nitinol. When the memory shape metal is freed from the lumen of a needle, the needle points, at the terminal ends of the metal arms, flare out laterally beyond the lumen of the needle. The arms are then pulled proximally, causing the needle points to penetrate the vessel wall from inside out. The needle points are then captured by suture catches which are also laterally disposed outboard of the delivery system. The catches pull the needle points and draw in the sutures.
U.S. Pat. No. 5,053,046 to Janese discloses a dural sealing needle. The dural ceiling needle includes a gelatin sealing compound that swells and sits between an impact cone cavity and an impact cone protrusion. Wings spread out based upon the swelling of the gelatin seal and assist in the retention of the suture seal.
U.S. Pat. No. 4,744,364 to Kensey discloses a flexible disc-shaped body at the end of a suture thread which expands after being pushed out from the lumen of a delivery needle. In the lumen, the body is contracted or compressed.
U.S. Pat. No. 4,741,330 to Hayhurst discloses an apparatus for anchoring cartilage. The anchor is deformed in the lumen of a delivery tube, is thereafter pushed from the tube and springs laterally outward upon exiting the tube. One of the embodiments of the suture includes a flexible anchoring device which has a U-shape when loaded within the delivery needle. Hayhurst also discloses that xe2x80x9cone end of the suture 12 may be securely attached to the anchoring device 10 during the molding or forming of the anchoring device. Preferably, the free opposite end 13 of the suture is hardened or stiffened as by impregnation with a suitable plastics material.xe2x80x9d col. 5, lines 21-26.
U.S. Pat. No. 4,705,040 to Mueller et al. discloses a suture with a T-shaped bar attached to the end of the suture. The bar is a stiff stainless steel tubing with an internal diameter of 0.025 inch and with a central hole formed in its side. The suture filament is fit within the hole and the bar heated to melt the end of the suture with the result that the resinous filament melts and draws into the form of a large central ball. When cooled and set, the ball is substantially larger than the hole, thereby creating a firm root for the filament within the bar.
U.S. Pat. No. 4,669,473 to Richards, et al., discloses a surgical fastener or suture with a t-bar formed out of a resilient polymerized resin. Richards T-shaped suture head has at least one portion of the T with a sharp point so that when the head portion is implanted in the body tissue, the head portion will attach itself securely to the tissue and will remain there despite a pulling force on the filament. The suture head is integral with the filament and the fastener is formed so that the head normally extends at a right angle to the adjoining length of filament.
U.S. Pat. No. 4,006,747 to Kronenthal, et al., discloses H-shaped fasteners constructed of a flexible and resilient biocompatible material. Each fastener has a filament with a rod-shaped head attached at either end. Kronenthal discloses an embodiment in which the heads are molded from the same material as the connecting filament. Kronenthal also discloses an alternative embodiment wherein stainless steel heads are each attached by swaging multifilament suture which enters the fastener head at the midpoint thereof with one end of the suture filament contained within one-half section of each head.
It is an object of the present invention to provide a suture which can be self secured on a bodily structure, tissue or organ with a toggle at the terminal end of the suture.
It is another object of the present invention to provide a generally T-shaped toggle which latches on an interior or inboard surface of a bodily structure, tissue and organ thereby permitting the balance of the suture to be drawn in and wherein the toggle grasps the bodily structure, tissue and organ.
It is a further object of the present invention to provide a toggle configured as a bar at the end of a suture.
It is another object of the present invention to provide a metal wire suture with a T-shaped toggle or a toggle wire element attached to the terminal end of a suture wire.
It is a further object of the present invention to provide a suture thread and a toggle wherein the toggle includes a protruding leg or tab which is utilized by a needle delivery system to insert the suture toggle into the bodily structure, tissue or organ.
It is a further object of the present invention to provide a self-securing suture toggle wherein the suture thread and toggle are attached to form an acute angle.
It is a further object of the present invention to provide a method of manufacture to produce self-securing suture toggles with toggles attached at an acute angle to the suture thread.
It is a further object of the present invention to provide a suture toggle in which an end segment of the suture thread is stiffened.
It is a further object of the present invention to provide a suture delivery system including a slotted needle, within which is seated the leg or tab of the toggle, which assists in the process of inserting the suture toggle into the bodily structure, tissue or organ.
It is another object of the present invention to provide a self securing suture with a toggle which can be used for minimally invasive surgical techniques.
It is a further object of the present invention to provide a suture delivery system and toggle sutures utilized in laparoscopic procedures.
The self securing suture includes a suture having a stiff end segment at a terminal end and a toggle disposed on the terminal end such that the stiff end segment and toggle define an acute angle between 25 degrees and 65 degrees. The toggle may include a metal body toggle or a biocompatible plastic body toggle. An embodiment of the suture toggle includes a biocompatible coating of the toggle and stiff end segment. In one embodiment, a portion of the stiffened end segment is swaged onto the toggle in a closed channel. In another embodiment, a portion of the stiffened end segment is swaged onto the toggle in a closed cutout. The present invention also includes methods for producing suture toggles. One method includes creating a partial channel on a toggle, stiffening an end segment of a suture thread, positioning a portion of the stiffened end segment in the partial channel, and swaging the toggle channel closed about the portion of the stiffened end segment lying therein. The method may include roughening the channel surface prior to swaging. The method may also include aligning the stiffened end segment and toggle such that the two define an acute angle. In addition, the method may also include the step of coating the toggle and stiffened suture thread with a biocompatible polymer after the swaging step. An alternative method of manufacture for producing the suture toggle includes the steps of creating a longitudinal passage through a toggle, forming a lateral hole through the toggle and into the passage, stiffening an end segment of a suture thread, placing the suture thread in the passage and through the hole of the toggle such that a portion of the stiffened end segment lies in the passage and protrudes from the hole, swaging the toggle closed about the captured stiffened end segment, and coating the toggle and the portion of the stiffened end segment of the suture thread with a biocompatible material. In yet another method of manufacture for producing a suture toggle, a mold is provided defining a toggle-shaped cavity and a suture thread-shaped cavity communicating therewith. The mold may also include a protruding member-shaped cavity communicating with the toggle cavity. The method includes stiffening a suture thread end segment, positioning the suture thread end segment within the suture thread cavity of the mold, and molding a toggle onto the positioned suture thread end segment at an acute angle utilizing the mold. This method may be utilized such that the positioning step occurs prior to the stiffening step, and the stiffening step occurs substantially concurrently with the molding step. The stiffening of the suture thread end segment may be accomplished by cold dipping same into a polymer or spraying the end segment with a biocompatible acrylic.